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kk444555 在 2023-10-17 22:13 回答了问题 cGMP 数据完整性: Is it acceptable to only save the final results from reprocessed laboratory chromatography?; kk444555: No. Analytical methods should be accurate and precise.16 For most lab analyses, reprocessing data should not be regularly needed. If chromatography is...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:11 回答了问题 cGMP 数据完整性: hy has FDA cited use of actual samples during “system suitability”？; kk444555: FDA prohibits sampling and testing with the goal of achieving a specific result or to overcome an unacceptable result (e.g., testing different samples...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:07 回答了问题 cGMP 数据完整性: When does electronic data become a CGMP record?; kk444555: When generated to satisfy a CGMP requirement, all data become a CGMP record.14 You must document, or save, the data at the time of performance to crea...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:06 回答了问题 cGMP 数据完整性: Can I use electronic signature instead of handwritten signature?; kk444555: Yes, electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record. Althou...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:05 回答了问题 cGMP 数据完整性: Is it acceptable to save paper printed records instead of original electronic records?; kk444555: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original record (see §§ 211.68...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:03 回答了问题 cGMP 数据完整性: Can electronic copies be used as accurate reproductions of paper or electronic records?; kk444555: Yes. Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:01 回答了问题 cGMP 数据完整性: How often should audit trails be reviewed?; kk444555: If the review frequency for the data is specified in CGMP regulations, adhere to that frequency for the audit trail review. For example, § 211.188(b) ...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:00 回答了问题 cGMP 数据完整性: Who should review audit trails?; kk444555: Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review t...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:59 回答了问题 cGMP 数据完整性: How should blank forms be controlled?; kk444555: There must be document controls in place to assure product quality (see §§ 211.100, 211.160(a), 211.186, 212.20(d), and 212.60(g)). For example, bound...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:57 回答了问题 cGMP 数据完整性: Why is FDA concerned with the use of shared login accounts for computer systems?; kk444555: When login credentials are shared, a unique individual cannot be identified through the login and the system would not conform to the CGMP requirement...; 赞同0 反对 0 人感谢 0 评论 1 回复

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